Stason Pharmaceuticals, Inc
FDA inspection history in Irvine, California, 2016 to 2021
- 3
- Form 483s
- 2
- Close-outs
Every document, by year
- Close-out
- Form 483
2016: one Form 483; 2019: one Form 483; 2020: one close-out letter; 2021: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Irvine, California.
- 2019–21Two Form 483s and two close-out letters, at Irvine, California.
- 2019The longest 483 on file: 15 observations over 11 pages at Irvine, California.
Cited most
Across all Stason Pharmaceuticals observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.192Production record review3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.160General requirements2
- 21 CFR 211.165Testing and release for distribution2
The complete Stason Pharmaceuticals file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Irvine, California
Three Form 483s and two close-out letters · 2016 to 2021 · 24 observations
Latest: Close-out, Jun 24, 2021 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-06-24 | Close-out Close-out letter | Irvine, California | — | $99 |
| 2021-04-13 | 483 Form 483 | Irvine, California | 2 | $99 |
| 2020-07-08 | Close-out Close-out letter | Irvine, California | — | $99 |
| 2019-10-25 | 483 Form 483 | Irvine, California | 15 | $99 |
| 2016-03-08 | 483 Form 483 | Irvine, California | 7 | $99 |
Investigators on these documents
Walden H. Lee (2)Cynthia Jim (1)Joey V. Quitania (1)Truong X. Nguyen (1)
FEI number 1000160561 · most recent document Jun 24, 2021
About Stason Pharmaceuticals, Inc
How many FDA Form 483s has Stason Pharmaceuticals, Inc received?
FDA Intel has 3 Form 483s on file for Stason Pharmaceuticals, Inc; the most recent is dated Apr 13, 2021.
When was Stason Pharmaceuticals, Inc last inspected by FDA?
The most recent FDA inspection document on file for Stason Pharmaceuticals, Inc is a Form 483 dated Apr 13, 2021, for the site in Irvine, California.
What did FDA cite at Stason Pharmaceuticals, Inc?
The regulations cited most in the observations on file for Stason Pharmaceuticals, Inc are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 4 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times.